Relapse-remitting Multiple Sclerosis (RRMS) Classification code 10048393
Conditions
Interventions
Product Name: Human monoclonal antibody (CNTO 1275) to interleukin-12p40
Product Code: CNTO 1275
Pharmaceutical Form: Powder for solution for injection
Current Sponsor code: CNTO 1275
Other descriptiv
Human anti-IL-12 Mab
Human anti-IL-12 IgG1 Mab
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Powder for solution for injection
Route of admini
Sponsors
Centocor B.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Be >/= 18 and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Have a CNS disease (eg, CNS lymphoma, systemic lupus erythematous) that could affect the interpretation of the functional disability scale scores. 2. Have significant bulbar involvement of MS or other neurologic deficits or history that would, in the judgment of the investigator, place the subject at significant risk of infectious complications. 3. Have a decubitus ulcer. 4. Have an indwelling foley catheter. 5. Have received any immunomodulating therapies (eg, interferon) within the 3-month period prior to screening. 6. Have received glatiramer acetate within the 3-month period prior to screening. 7. Have ever received cladribine or any chemotherapeutic agents (eg, mitoxantrone). 8. Have received systemic corticosteroids within the 1-month period prior to screening. 9. Have received any previous treatment with CNTO 1275 or any other investigational agent for the treatment of MS that is known to target IL-12 or IL-23. 10. Have received treatment in a clinical study within 3 months prior to screening or within 5 half-lives (if known) of an investigational agent, whichever is longer. The Sponsor may grant inclusion approval on an individual basis if it is determined unlikely that the investigational agent would have an effect on MRI lesions during the screening or treatment period. 11. Are pregnant, nursing, or planning pregnancy (both men and women) within 1 year after the last study agent injection(s). 12. Have a history of a previous immediate hypersensitivity response including anaphylaxis or a severe allergic reaction to monoclonal antibodies. 13. Have a chest x-ray at screening or within 2 months prior to screening that shows evidence of malignancy, infection, or any abnormalities suggestive of TB as described in Section 4.3.2. of the protocol. 14. Have laboratory evidence of any of the following: * Hemoglobin 1.5 times the upper limit of normal for the clinical laboratory * Serum creatinine levels > twice the upper limit of the normal reference rangefor the clinical laboratory, unless calculated creatinine clearance is > 30mL/min. 15. Have a serious infection (eg, hepatitis, pneumonia or pyelonephritis), a chronic or serious recurring infection, hospitalization for infection, or treatment with IV antibiotics for infection within 2 months prior to screening. Less serious infections (eg, acute upper respiratory tract infection or uncomplicated urinary tract infection) need not be considered exclusions at the discretion of the investigator. 16. Have or have had opportunistic infections (eg, cytomegalovirus [CMV], Pneumocystis carinii, histoplasmosis or any mycobacterial infection other than TB) within 6 months prior to randomization. 17. Have a known or suspected diagnosis of asthma. 18. Have documented current or past infection with hepatitis B or C. 19. Have documented human immunodeficiency virus (HIV) infection. 20. Have presence of a transplanted organ (with the exception of a corneal transplant performed > 3 months prior to randomization). 21. Have a known malignancy or history of malignancy within the previous 5 years (with the exception of basal cell carci
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to assess the dose-response effect of multiple subcutaneous (SC) injections of CNTO 1275 in subjects with RRMS based on the cumulative number of new gadolinium (Gd)-enhancing T1-weighted lesions on cranial MRIs through week 23.;Secondary Objective: The secondary objectives of this study are to assess the clinical response and safety of multiple SC injections of CNTO 1275 and to describe the pharmacokinetics after repeated doses of CNTO 1275 in subjects with RRMS.;Primary end point(s): The cumulative number of new Gd-enhancing T1-weighted lesions on cranial MRIs through week 23. | — |
Countries
Czech Republic, Hungary, United Kingdom
Outcome results
None listed